6 months ago
Job title: Regulatory Affairs Senior Associate, Global Publishing
A Biopharmaceutical company in Oxfordshire are seeking a Senior Associate, Global Publishing to join their Regulatory Operations team. This role will be responsible for the preparation and publishing of documentation for commercial and development submissions to global health authorities.
- Support Regulatory Affairs team in planning, publishing, submission, and archive of regulatory documents.
- Prepare and publish regulatory submissions in eCTD format, including, but not limited to: amendments; supplements; periodic/annual reports; promotional materials and meeting packages.
- Work across company disciplines and represent Global Regulatory Operations on assigned project and/or task teams to effectively communicate and drive timings and deliverables.
- Maintain records in Regulatory Information Management (RIM) system.
- Direct experience with publishing, compiling, preparing and QC of documents for eCTD submissions.
- Demonstrates a working knowledge of Regulatory Information Management system and publishing technologies. Experience with Global Submit Review/Publish, ISIToolBox, Starting Point templates, and Veeva Vault a plus.
- 3+ years of Regulatory Operations experience preferred.
Salary and benefits:
A competitive salary, annual bonus and wider benefits package is on offer with this role.
To apply for this position or hear further details then please contact Matt Thomas via firstname.lastname@example.org